Local TCM firm fined and warned for 'serious lapses'
HSA also issues stern warning but says no safety concerns with local firm's products
A local pharmaceutical company was issued a stern warning and fined after its manufacturing process was found to have serious lapses.
The Health Sciences Authority (HSA) carried out an investigation after health authorities received a tip-off in June, which alleged that the company had manipulated lab test data for its products.
Teda Pharmaceutical, which manufactures traditional Chinese medicine (TCM), had allegedly claimed its products did not have dangerous bacteria without lab tests to verify it.
In e-mail correspondence seen by The New Paper, it was alleged that a quality assurance manager at the company had told subordinates to sign off on the non-existent tests and to falsify production dates on the medicines to achieve a later expiry date.
The e-mails noted: "For pharmaceutical companies manufacturing medicine products taken by patients, it is important for its staff to be honest in their work procedures."
It was also alleged that the weights of some medicines were falsely labelled to save the trouble of reworking on them to get the correct weight.
When TNP contacted HSA in July, it said that it was looking into the allegations.
An HSA spokesman told TNP last week that its investigations had confirmed serious lapses by the company, without providing specific details.
SAMPLES TESTED
The authority said it had issued a stern warning and imposed financial penalties on Teda for the serious lapses. However, HSA added that it did not find any safety concerns after testing samples of the products.
"HSA has detected serious non-conformities in documentation, data management and records during a routine inspection of Teda Pharmaceutical," the spokesman said.
"Although Teda's products were found not to pose any safety concerns, HSA has mandated that the company outsource the testing of its products to a third party-accredited laboratory."
She said Teda's in-house quality control laboratory testing activities were suspended from Sept 23, and HSA will re-inspect the facility before deciding whether to lift the suspension.
HSA advises concerned consumers to discuss the availability and suitability of alternative medication with their physicians.
Teda's products, including pills for constipation, headaches and other ailments, are distributed by Litran Trading.
Teda was registered in 2003, with a majority of its shares held by Litran. Both companies also share the same board of directors, business records show.
Litran, which shares the same registered address as Teda at Toh Guan Road E, was established in 1979. Its website says that Teda implemented a quality assurance management system to "meet and possibly exceed the requirements" under quality regulations.
TNP's attempts to reach Teda managing director Ngon Pock Wang and senior executives were unsuccessful.
Teda is not a member of the Medicine Manufacturing Association of Singapore, but Mr Ngon sits on its committee on behalf of Litran, which is a member.
The association aims to encourage the production of good quality and effective medicine, says its website.
One of its committee members said it was aware of the case involving Teda, but the association was not able to comment.
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